Pulmonary emphysema is a common pulmonary disease. Traditional internal therapies for pulmonary emphysema include oxygen inhalation, pulmonary infection prevention, bronchus spasm relaxation and the like, but the curative effect is extremely limited. Surgical therapies for pulmonary emphysema mostly adopt lung volume reduction surgery, and there are also many limitations, for example: strict surgical indications, risks of many complications, anesthesia and anesthesia-related complications, difficulty in curative effect prediction before the surgery, and an irreparable non-ideal curative effect caused by over-cutting or sub-cutting after the surgery, excessively high surgical costs, and great mental and physical sufferings. In addition, some patients cannot always tolerate the surgery due to their poor lung functions, which leads to a higher postoperative mortality rate, thereby limiting the application of surgery.
In order to better treat pulmonary emphysema, to improve quality of life for a patient, and to reduce traumas to the patient during surgery, international research has tried to use a bronchoscope to implement interventional modes such as a one-way valve, biogel, steam thermal ablation, and elastic coils for treating pulmonary emphysema. However, the one-way valve has been rejected by the FDA (Food and Drug Administration) in the United States due to its low clinical indicators that residual gas and sputum in a target region cannot be effectively and actively excreted, and technical difficulties in collateral ventilation and precise placement of the one-way valve at different anatomical structural positions also limit the curative effectiveness of the one-way valve. The problem with the biogel completely blocking an emphysema region and leading to postoperative inflammation is still unsolved. Steam thermal ablation often leads to postoperative inflammation due to a defect of destroying an original tissue structure of the emphysema region.
At the present, an updated therapy method is being adopted for pulmonary emphysema, where an elastic coil serving as an implant is implanted into a lesion portion of the lung of a human body. FIG. 1 is a schematic diagram of a lung volume reduction elastic coil in the prior art. This product is designed and made of a nickel-titanium memory alloy metal wire, and may elastically deform under the action of an external force. Under the restriction of a loading system, this product may be implanted into a lung through a working channel of a bronchoscope in a straight line configuration. After being delivered into a bronchus of a pulmonary emphysema region, the coil is released from the restriction of the loading system and then recovers to its natural shape (which is a shape without the external force) as shown in FIG. 1, and at the same time, the emphysema region is squeezed under the pulling action of the nickel-titanium alloy wire, thereby discharging gas in the bronchus and reducing the volume of a lung tissue in the pulmonary emphysema region. This results in a relatively healthy lung tissue therearound that can provide a better physiological function.
A surgical method using the elastic coil includes three operation processes of inserting a bronchoscope, building a channel and implanting a product. Insertion of the bronchoscope is as shown in FIG. 2: a bronchoscope 201 is inserted through a mouth or a nose, and may display an image detected by the distal end 203 of the bronchoscope 201 on a monitor 204, thereby guiding the bronchoscope 201 to reach the bronchus 205 of a human lung.
Building of the channel is as shown in FIG. 2. The outer diameter of a guide wire 206 is about 5 Fr to 7 Fr, and the diameter of a delivery sheath may be about 5 Fr to 9 Fr. The guide wire 206 is moved to pass through an inner cavity of an expander 207, and the expander 207 is moved to pass through an inner cavity of the delivery sheath 208; after being assembled, the guide wire 206, the expander 207 and the delivery sheath 208 enter the bronchoscope 201 together from a working channel 202 of the bronchoscope 201, and then pass through the distal end 203 of the bronchoscope 201 and enter the bronchus 205. A length label 210 is disposed at the distal end 209 of the guide wire 206, and indicates a distance along the guide wire 206 from the distal end 209. The distal end 211 of the delivery sheath 208 may have multiple corresponding labels 210 in the form of high-contrast metal straps (including gold, platinum, tantalum, iridium, tungsten and/or metalloids). A fluorescence inspection system, an ultrasonic imaging system, an MRI (Magnetic Resonance Imaging) system, or an X-ray CT (Computerized Tomography) system, which are provided with a remote imaging and capturing device 212, or some other remote imaging implants, are configured to guide the guide wire 206. As shown in FIG. 2, the remote imaging and capturing device 212 may display a detected image on a monitor 213, and identify a track of the guide wire 206 or an imaging label 210, thereby building the channel.
After the channel is built, the expander 207 and the guide wire 206 are pulled out towards the proximal end from the delivery sheath 208, so that a lung volume reduction elastic coil 301 may be loaded in an open cavity of the delivery sheath 208. Implantation of the coil 301 is shown in FIG. 3, and the loading system 302 with the coil 301 is connected to the proximal end of the delivery sheath 208 through a locking hub connector 303. The coil 301 is introduced into the delivery sheath, as shown in FIG. 4, and a steel cable 305 of an actuation device 304 pushes the product out of the distal end of the delivery sheath 208 and enables the product to enter the bronchus 205. Then the delivery sheath 208 is withdrawn, and a gripper 306 of the actuation device 304 is configured to release the coil 301. When recovering to its initial shape, the coil 301 also pulls the bronchus 205 to be in a curled shape, thereby achieving a pulmonary emphysema volume reduction treatment effect.
The above-mentioned implant and its implantation method have the following defects:
1. An elastic coil is required to be released through a delivery sheath which may injure the inner wall of a bronchus during its pushing in the bronchus and cause adverse events such as pneumothorax.
2. As the delivery sheath has a relatively large outer diameter of about 5 Fr to 9 Fr, it is really difficult to implant the elastic coil into a lung bypass or the ends of some small-diameter tracheas, and only a limited pulmonary emphysema region is squeezed and pulled by the elastic coil, thereby affecting the volume reduction effect.
3. The existing surgical method for implanting an elastic coil requires three independent operation processes of inserting the bronchoscope, building the channel and implanting the product, so that a relatively long operation time is needed. In addition, as the surgery is conducted when a patient is awake, extremely long operation time may easily lead to adverse events such as discomfort of the patient and acute exacerbation of a COPD (Chronic Obstructive Pulmonary Disease).